GxP-Regulated Archives and the GxP Archivist

The primary focus of this course is on the implementation of archive procedures within an organisation and the operation of an archive in compliance with GxP (GLP, GCP, GMP). Previously, separate courses were offered for GLP Archivists and for GCP Archivists. The courses have now been combined into a single course as 90% of the content was the same for both courses. It is also beneficial for professional development to understand how GLP and GCP requirements differ from each other and from other requirements. The principles of archiving covered in this course are also relevant for any research or scientific archive. Topics covered are:

  • GxP Records Management Principles
  • Archive-related GxP Regulations
  • The GxP Archivist
  • The GxP Archive
  • Outsourcing GxP Archives

The course is delivered as a one-day training course, or as a series of webinar modules. The webinar modules (corresponding to the topics above) may be booked individually so there is no obligation to complete all five modules. Each module is approximately one hour duration. For a more detailed description of the course contents, click here.

Certificates of attendance are provided.

Location and dates – classroom training:

Please contact us to register your interest in attending this course. When we have sufficient numbers, we will contact you to determine the best location and time.

On-demand Webinars:

Please select the link below to access this training programme on demand. Please note that following payment, you will immediately be taken to the webinar recording.  However, you will also receive a registration confirmation email with a join link to enable you to watch the recording at any time up to the stated expiry date of the webinar. NEW FEATURE: It is now possible to pause the recording and go backwards and forwards to any point during the recording. This means that you no longer need to attend the whole webinar at a single sitting. You will receive a certificate by automated email within 24hrs of accessing the recorded webinar. HSRAA regrets it is unable to send certificates manually due to a limitation of the webinar software we are using.

MODULE 1: Records Management Principles

MODULE 2: Archive-related GxP Regulations

MODULE 3: The GxP Archivist

MODULE 4: The GxP Archive

MODULE 5: Outsourcing GxP Archives

Prices

Please note that the US-based training platform we use only provides for charging in US Dollars. To calculate the rate you will be charged in your local currency, please check the  current exchange rate, No tax/VAT is charged as HSRAA are not registered for VAT.

Cost per webinar module: $65 HSRAA Members / $80 Non-members (approx £50 / £60)
Cost for complete webinar course (20% discount): £200 HSRAA Members / £240 Non-members. Click HERE to purchase the complete series.
Cost of 1-day classroom course (including lunch & refreshments): £380 HSRAA Members / £440 Non-members.

A discounted price is available for HSRAA members. If you are a member, click HERE.

Payment Please note that we do not have the facility to generate invoices manually and to take offline payments. We use third-party booking systems that only provide for online payment by credit/debit card. If you do not have access to a company/corporate card, please make a payment using your personal card and use your company’s standard process for employee reimbursement of expenses i.e. the same process as out-of-pocket travel expenses that you would reclaim.